Abstract
BACKGROUND: With the incidence of breast cancer rising worldwide, we are evaluating the iBreastExam (iBE) (UE LifeSciences Inc.), a handheld breast scanning device that can be utilized by community health workers to screen for breast abnormalities. The purpose of this study is to determine the sensitivity of the iBE in a population undergoing diagnostic breast imaging. METHODS: Adult patients presenting to a breast imaging center for a diagnostic workup were eligible. Patients underwent an iBE exam performed by a trained ultrasound technician followed by their indicated imaging. Demographic, imaging, and biopsy data were recorded. RESULTS: Seventy-eight iBE exams were completed, 77 females and one male with a mean age of 42 (21-79). All patients were evaluated by ultrasound, 52 had diagnostic mammography and 39 had biopsies. Imaging and/or biopsy confirmed a mass (fibroadenoma, cyst, papilloma, myofibroblastoma, fat necrosis, DCIS, or cancer) in 60 patients. Twelve patients had a cancer diagnosed. In total, 342 quadrants were scanned, 77 quadrants had lesions confirmed on imaging, and iBE correctly identified 66 lesions for a sensitivity of 86 % and specificity of 89 %. CONCLUSIONS: This validation study demonstrated excellent sensitivity of iBE for the identification of clinically significant lesions in patients presenting for diagnostic imaging. TRIAL REGISTRATION: A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study: NCT02814292 .